A Study of Factor XIII Concentrate in Subjects With Congenital Factor XIII Deficiency

This study has been completed.

Sponsor:

CSL Behring

ClinicalTrials.gov Identifier:

NCT00885742

First Posted: April 22, 2009

Last Update Posted: July 16, 2012

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Number of subjects with any treatment-emergent adverse event (AE), treatment-related AE or serious AE (SAE). Treatment related AEs are defined as AEs whose relationship to study treatment is related, or possibly related, and AEs with missing relationship.

Peak FXIII Concentration at Steady State [ Time Frame: At 12, 24, 36 and 48 weeks: at 30 and 60 minutes after the end of the infusion. ]

Trough FXIII Concentration at Steady State [ Time Frame: At 12, 24, 36 and 48 weeks: immediately before infusion. ]

Time to Peak Concentration [ Time Frame: At 12, 24, 36 and 48 weeks: immediately before infusion, then at 30 and 60 minutes after the end of the infusion. ]

Incremental Recovery [ Time Frame: At 12, 24, 36 and 48 weeks: immediately before infusion, then at 30 and 60 minutes after the end of the infusion. ]

All subjects who received a dose of Factor XIII (FXIII) Concentrate (Human).

Biological: FXIII Concentrate (Human)

Doses will be guided by the individual subject's most recent FXIII activity levels, with the objective of dosing every 28 days to maintain a trough FXIII activity level of approximately 5 to 20%.

Subjects enrolled in this study who did not complete the pharmacokinetic study (Factor XIII Study BI71023_2002 [NCT00883090]) will initially receive FXIII Concentrate (Human) at a dose of 40 U/kg by intravenous (IV) infusion.

Other Name: Fibrogammin-P

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:

Child, Adult, Senior

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Written informed consent/assent for study participation obtained before undergoing any study-specific procedures

Administration of a FXIII-containing product, including blood transfusions or other blood products within 4 weeks prior to the planned Day 0

Any known congenital or acquired coagulation disorder other than congenital FXIII deficiency

Known or suspected to have antibodies towards FXIII

Use of any other investigational medicinal product within 4 weeks prior to the Baseline Visit (Day 0)

Known Positivity for human immunodeficiency virus (HIV) or a positive result for HIV at the Screening Visit of this study or the FXIII study 2002 (NCT00883090).

Serum aspartate transaminase (AST) or serum alanine transaminase (ALT) concentration >2.5 times the upper limit of normal at the Screening Visit of this study or at the Day 56 Visit of Factor XIII Study BI71023_2002 (NCT00883090)

Fibrinogen level less than 85% of the lower limit of normal at the Screening Visit of this study or the Factor XIII Study BI71023_2002 (NCT00883090)